FDA 510(k) clearance · back to tracker

GEN-PROBE RAPID DIAGNOSTIC SYSTEM FOR MYCOBACTERIA

Gen-Probe, Inc. cleared K864597 on 1987-04-20, decision: substantially equivalent

K-number

K864597

Sponsor

Gen-Probe, Inc.

Device

GEN-PROBE RAPID DIAGNOSTIC SYSTEM FOR MYCOBACTERIA

Class

Class I

Decision

Substantially Equivalent

Decision date

1987-04-20

Product code

LQF

Advisory committee

Microbiology

Medical specialty

Microbiology

Regulation number

866.3370

Official FDA record

Open K864597on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

Use this as a predicate

Drop K864597 into Compass and start a substantial-equivalence draft.

Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.

Try the sandbox

Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.